Status:
COMPLETED
The Effect of Linagliptin (BI 1356) on 24h-glucose Control and Various Biomarkers in Type 2 Diabetic Patients
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The objective of this study is to investigate the effect of BI 1356 on 24-h glucose control and various pharmacodynamic parameters in type 2 diabetic patients with inadequate glycaemic control.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with not more than one drug
- Glycosylated haemoglobin A1 (HbA1c) 6.5 to 10.0% at Start of Run-in
- Exclusion criteria:
- Myocardial infarction, stroke or transient ischemic attack "TIA" within 6 months prior to informed consent
- Impaired hepatic function
- Renal insufficiency with a creatinine clearance \< 50 mL/min
- Treatment with rosiglitazone, pioglitazone, glucagon like peptide 1 (GLP-1) analogues, insulin, dipeptidyl peptidase 4 (DPP-4) inhibitors or anti-obesity drugs 3 months prior to informed consent.
Exclusion
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT00716092
Start Date
July 1 2008
Last Update
June 27 2014
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
1218.37.49003 Boehringer Ingelheim Investigational Site
Berlin, Germany
2
1218.37.49002 Boehringer Ingelheim Investigational Site
Mainz, Germany
3
1218.37.49001 Boehringer Ingelheim Investigational Site
Neuss, Germany